Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Enhanced standard care for treating mechanical neck pain

Official title: A Two-Center, Investigator-Blinded, Randomized, 4-Week, Parallel-Group, Superiority Study Comparing Contextual Factors-Enriched Standard Care Versus Standard Care Only for Patients With Mechanical Neck Pain (ContextualizAR Trial)

Run by Universidad Nacional de la Matanza · NCT06361472 · Data updated 2026-11-12

This study is testing if adding extra support for physical, mental, and social factors to standard care can help people with neck pain feel better and improve their daily activities.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment94 (estimated)
SponsorUniversidad Nacional de la Matanza
Academic / other
Locations2 sites (Ciudad Autónoma de Buenos Aires, Buenos Aires and 1 other locations)
StatusRecruiting
StartedMay 2, 2024
Main results expectedApril 2027
Study endsJuly 2027
Registry record updatedJuly 8, 2026
Trial IDNCT06361472 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with neck pain persisting for more than 4 weeks and no major structural pathology.

Probably not a fit

Patients with minor neck pain, recent cervical spine trauma, or serious underlying conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a Contextual Factors-Enriched Standard Care (CFs+SC) approach compared to standard care alone for patients suffering from mechanical neck pain. Over a 4-week period, participants will receive treatment twice weekly, with the intervention group benefiting from additional contextual factors that address physical, psychological, and social elements of care. The study will measure outcomes such as pain reduction and functional improvement using validated questionnaires and scales. The trial will also explore the impact of psychosocial conditions on treatment efficacy.

Why it matters

Potential benefit: If successful, this approach could significantly reduce pain and improve functional status for patients with mechanical neck pain.

How similar studies have gone: While the specific CFs+SC approach may be novel, similar studies have shown promise in enhancing treatment outcomes through contextual factors.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Aged \>18.
* Neck pain for more than 4 weeks without signs or symptoms suggestive of major structural pathology.
* Read, write, and understand the Spanish language.
* Signed consent form.

Exclusion Criteria:

* Numeric Pain Reporting Scale (NPRS) \< 3 points (to ensure the exclusion of patients with minor disorders).
* Northwick Park Neck Pain Questionnaire (NPQ) \< 10 points (to ensure the exclusion of patients with minor disorders).
* History of cervical spine trauma, fracture, or surgical procedures.
* Signs and symptoms of cervical myelopathy and/or cervical radiculopathy (to rule out cervical radicular pain, the Spurling Test, the Upper Limb Tension Test for the median nerve, and the Traction/Distraction test will be used).
* Red flags or serious pathologies, such as malignancy, inflammatory or rheumatic diseases, infections, and vascular conditions like cervical artery insufficiency.

Where it's running

  • Hospital Carlos G. Durand
    Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
    Recruiting
  • Hospital Donación Francisco Santojanni
    Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.